Third Party Accreditation Rule

Third Party Rule

The Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Third Party Accreditation) final rule is an attempt by FDA to leverage its oversight capabilities, establishing a mechanism whereby private auditors are accredited by FDA to issue food safety certifications to foreign food facilities.  These certifications will be required for participation in the Voluntary Qualified Importer Program (VQIP).

Under the  final rule, FDA would recognize accreditation bodies, which would in turn accredit the third-party auditors/certification bodies that would actually audit and issue certifications to qualifying foreign facilities.  In order to be recognized by FDA, the accreditation bodies would have to submit to certain FDA requirements themselves and impose certain requirements on the entities they accredit.  For example, if an auditor or certification body identifies certain conditions that present a serious health risk, the auditor must report it to the accreditation body, which must report it to FDA. In addition, all reports and records issued under the authority of an FDA-recognized accreditation body must be in English. To learn more about the Third Party Accreditation final rule go to the GMA Resources section below.

Update (11/27/2015): On November 27, 2015, three final rules were published to the Federal Register: Accredited Third-Party Certification, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, and Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.

Important Dates: The Third Party Accreditation Rule requires FDA to first publish Model Accreditation Standards before covered entities can apply for accreditation or certification. FDA has not announced when it expects to release draft Model Accreditation Standards.

Links to GMA Resources:

In-Depth Analysis of the Third Party Accreditation Proposed Rule
GMA Comments on the Third Party Accreditation Proposed  Rule
FSMA Timeline and Milestones
GMA Reference Sheet for FSMA Compliance Dates
GMA Summary Reference Sheet for FSMA Compliance Dates
Hogan Lovells Memorandum

Links to FSMA Documents:

Full Text of the Third Party Accreditation Proposed Rule
Full Text of Third Party Accreditation Final Rule
Third Party Accreditation PRIA

Links to FDA Resources:

FDA’s Third Party Accreditation Rule page
Third Party Accreditation Docket

Contact Information: Kristen Spotz

Disclaimer: The materials on this website are provided for informational purposes only and do not constitute legal advice. GMA does not advise on the application of law to an individual’s or company’s specific circumstances.  Although we go to great lengths to make sure our information is accurate and useful, we recommend you consult a lawyer if you want professional assurance that our information, and your interpretation of it, is appropriate to your particular situation.